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Sodium oxybate [Xyrem] for the treatment of Fibromyalgia – Source: Expert Opinion on Pharmacotherapy, Jun 16, 2011

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Introduction: Gamma-hydroxybutyrate (GHB) is a short-chain fatty acid that is synthesized within the central nervous system, mostly from its parent compound gamma amino butyric acid (GABA).

GHB acts as a neuromodulator/neurotransmitter to affect neuronal activity of other neurotransmitters and so, to stimulate the release of growth hormone.

Its sodium salt (sodium oxybate: SXB) was approved by the Food and Drug Administration (FDA) for the treatment of narcolepsy.

SXB has shown to improve disrupted sleep and increase NR3 (slow-wave restorative) sleep in patients with narcolepsy.

It is rapidly absorbed and has a plasma half-life of 30 – 60 minutes, necessitating twice-nightly dosing.

Most of the observed effects of SXB result from binding to GABA-B receptors.

Areas covered: Several randomized, controlled trials demonstrated significantly improved fibromyalgia (FM) symptoms with SXB.

As seen in narcolepsy trials, SXB improved sleep of FM patients, increased slow-wave sleep duration as well as delta power, and reduced frequent night-time awakenings.

Furthermore, FM pain and fatigue was consistently reduced with nightly SXB over time.

Commonly reported adverse events included headache, nausea, dizziness and somnolence.

Despite its proven efficacy, SXB did not receive FDA approval for the management of FM in 2010, mostly because of concerns about abuse. [Sodium Oxybate is the infamous ‘date rape drug.’]

Expert opinion: Insomnia, fatigue and pain are important clinical FM symptoms that showed moderate improvements with SXB in several large, well-designed clinical trials.

Because of the limited efficacy of currently available FM drugs additional treatment options are needed. In particular, drugs like SXB – which belong to a different drug class than other Food and Drug Administration (FDA)-approved FM medications such as pregabalin, duloxetine and milnacipran – would provide a much-needed addition to presently available treatment options.

However, the FDA has set the bar high for future SXB re-submissions, with requirements of superior efficacy and improved risk mitigation strategies.

At this time, no future FDA submission of SXB for the fibromyalgia indication is planned.

[Note: Xyrem is a costly drug, at a cost per patient of about $30,000 per year. The maker, Jazz Pharmaceuticals, has hiked the price 220% since 2008, including an increase of 22% in November 2010 and another 18% in April 2011, according to www.investors.com – with an additional 71% boost reportedly projected “by the end of 2014.”

Source: Expert Opinion on Pharmacotherapy, Jun 16, 2011. PMID:21679091, by Staud R, University of Florida – medicine, Gainesville, Florida, USA [Email: Roland.Staud@medicine.ufl.edu]

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5 thoughts on “Sodium oxybate [Xyrem] for the treatment of Fibromyalgia – Source: Expert Opinion on Pharmacotherapy, Jun 16, 2011”

  1. Daisys says:

    It’s too bad that Xyrem isn’t more available for those with FM. After taking my first dose, I felt like I’d gotten my mind back, thinking clearly all day and not feeling the need for a nap. It’s changed my life tremendously for the better.

    For negative side effects, the most common are discussed at the Talk About Sleep site, and certain nutrients help with most of the problems that are encountered while getting used to xyrem.

    This substance was sold in health food stores for years, and was not expensive. It natually occurs in the brain during deep sleep and the end products of processing it are water and carbon dioxide, so the liver and kidneys are not even involved in the process.

    Many people got a good night’s sleep with the product, until some evil people abused it, using it to rape. This brings up an important point: the women who were raped probably had normal sleep, and were probably drinking at the time they were given GHB.

    With my revved up central nervous system, I can wake up while on xyrem, just like a normal person in a deep sleep–it may take a couple of firm shakes, and I have to be careful, because I’m clumsy until the xyrem wears off. I don’t normally do this, but wanted to make sure I could wake up in case of emergency.

    Xyrem can be abused, and can be addictive. If taken as directed, the addiction never happens. I trust my household, and don’t discuss what I take for sleep openly. I don’t leave it out when children are around, and ask the parents to keep them out of my private rooms.

    I have Lyme disease, which may be the cause of FM, or it may be a separate issue. So, while I still have symptoms and am ill, the FM part of my profile is definitely no longer on top of my list of symptoms.

    I’m very thankful that I found a doctor willing to prescribe Xyrem off label, and that my insurance covers it. I wish it was available to all with FM.

    1. Daisys says:

      I wanted to add that I had written in a lot of paragraphs, and it’s too bad it’s been printed in one solid paragraph–so hard to read!

    2. lorreann says:

      I want to try Xyrem. Did you have a sleep doctor or Fibro doctor prescrbe it? Also, what type of insurance do you have?

  2. healthy51 says:

    I used Xyrem for 6 years and my fibro pain went away. They were 6 wonderful years of great sleep as well. But then after 6 years my insurance company said I could no longer get it as I did not have narcolepsy.

    It now costs near to $3000 a month. Although one can get it discounted. But it is still way too expensive to be able to afford it on a monthly basis.

    Wish they would lower the cost so more of us could afford it. It does wonders for sleep and the pain of fibromyalgia.

  3. gorgia098 says:

    Great stuff here. The information and the detail were just perfect. I think that your perspective is deep, its just well thought out and really fantastic to see someone who knows how to put these thoughts down so well. Great job on sodium oxybate. I didn’t know it containg lot of salt.

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